注射用乙酰左卡尼汀细菌内毒素检查方法的建立  

Establishment of bacterial endotoxins test in acetyl-L-carnitine for injection

作　　者：于海洲 鲁凯强 于风平 冯巧巧 YU Haizhou;LU Kaiqiang;YU Fengping;FENG Qiaoqiao(Yantai Center for Food and Drug Control/Test,Yantai 264670,China;Suzhou Industrial Park Center for Medical Products Administration,Suzhou 215000,China;Shandong Center for Food and Drug Evaluation and Inspection,Ji’nan 250022,China)

机构地区：[1]烟台市食品药品检验检测中心,山东烟台264670 [2]苏州工业园区药品管理中心,江苏苏州215000 [3]山东省食品药品审评查验中心,济南250022

出　　处：《中国药品标准》2022年第3期322-325,共4页Drug Standards of China

摘　　要：目的:建立注射用乙酰左卡尼汀细菌内毒素检查方法。方法:按照《中国药典》2020年版四部通则1143细菌内毒素检查法的要求,采用两个不同厂家的鲎试剂,对3批注射用乙酰左卡尼汀进行了预干扰试验与干扰试验。结果:当质量浓度为0.50 mg·mL^(-1)及以下时,供试品溶液对鲎试剂与细菌内毒素之间的凝集反应无干扰;供试品的细菌内毒素限值拟定为0.25 EU·mg^(-1)。结论:建立的细菌内毒素检查方法适用于注射用乙酰左卡尼汀。Objective:To establish a bacterial endotoxin test method for acetyl-L-carnitine for injection.Methods:According to the requirements of general chapter 1143 bacterial endotoxin test in the Chinese Pharmacopoeia 2020 VolⅣ,the pre-interference test and interference test were carried out on three batches of acetyl-L-carnitine for injection with tachypleus amebocyte lysate reagents from two different manufacturers.Results:When the mass concentration was 0.50 mg·mL^(-1) or less,the test solution had no interference with the agglutination reaction between tachypleus amebocyte lysate and bacterial endotoxin.The bacterial endotoxin limit of the sample was proposed to be 0.25 EU·mg^(-1).Conclusions:The bacterial endotoxin test method established in this paper is suitable for acetyl-L-carnitine for injection.

关 键 词：注射用乙酰左卡尼汀 细菌内毒素检查 鲎试剂 干扰试验 

分 类 号：R921.2[医药卫生—药学]